Ulcerative Colitis
Conditions
Sponsors
Eli Lilly Japan K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Have completed Study AMAN, with at least 1 study drug administration and without early termination of study drug. -Are willing and able to complete the scheduled study assessments, including endoscopy and daily diary entry. -If female, must meet the contraception requirements.
Exclusion criteria
Exclusion criteria: -Participants diagnosed with Crohn's disease or inflammatory bowel disease-unclassified (indeterminate colitis) during the induction study AMAN. -Participants with a bowel resection or other surgery for the treatment of UC during the previous induction study AMAN, or are likely to require surgery for the treatment of UC during study AMBG. -Participants with evidence of colonic dysplasia or have been diagnosed with cancer of the gastrointestinal tract during study AMAN . -Participants diagnosed with clinically important infection including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during the induction study AMAN. -Participants who initiate a new prohibited medication during the induction study AMAN. -Participants with certain laboratory abnormalities prior to start of AMBG that would require permanent discontinuation from study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Percentage of Participants in Clinical Remission [ Time Frame: Week 40 ] | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy pharmacokinetics -Percentage of Participants in Endoscopic Remission [ Time Frame: Week 40 ] -Percentage of Participants with Histologic Remission [ Time Frame: Week 40 ] -Percentage of Participants in Symptomatic Remission [ Time Frame: Week 40 ] -Percentage of Participants in Endoscopic Response [ Time Frame: Week 40 ] -Percentage of Participants in Clinical Response [ Time Frame: Week 40 ] -Change from Baseline to Week 40 in Health Related Quality of Life [ Time Frame: Baseline, Week 40 ] -Change from Baseline to Week 40 in Fecal Calprotectin [ Time Frame: Baseline, Week 40 ] -Change from Baseline to Week 40 in Ulcerative Colitis (UC) Symptoms: Numeric Rating Score (NRS) [ Time Frame: Baseline, Week 40 ] -Percentage of Participants Hospitalized for UC [ Time Frame: Week 40 ] -Pharmacokinetics (PK): Clearance of Mirikizumab [ Time Frame: Weeks 0, 4, 12, 24, and 40 ] | — |
Countries
Asia except Japan, Europe, Japan, North America, Oceania, South America
Outcome results
None listed